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Cohort Follow-up of Patients With Renal or Craniocervical Fibromuscular Dysplasia

NCT02961868 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2019-09-23

No results posted yet for this study

Summary

PROFILE is a cohort study evaluating the progression of fibromuscular dysplasia lesions. This study is the prospective dimension of ARCADIA registry (ClinicalTrials.gov Identifier: NCT02884141), which aims to document phenotypic and genetic traits in patients with renal and/or cervical artery fibromuscular dysplasia.

Conditions

  • Fibromuscular Dysplasia

Interventions

OTHER

Abdominal and supra-aortic trunks vascular imaging

Abdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or MR-angiography) will be performed 3 years after inclusion. This imaging will be compare to initial imaging (which is a part of usual care, not an intervention added by the study) in order to assess FMD progression.

GENETIC

Blood sampling (genetic)

A sample of blood will be taken to meet the objective of estimating the rate of genetic polymorphism that may influence disease progression or be associated with complications.

OTHER

Blood sampling (biomarkers)

A sample of blood will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.

OTHER

Urine sampling

A sample of urine will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.

Sponsors & Collaborators

  • Fondation de Recherche sur l'Hypertension Artérielle

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Pierre-François Plouin, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Belgium
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02961868 on ClinicalTrials.gov